The clinical efficacy and safety of fluticasone propionate ointment, 0.005%, were compared with those of its vehicle in the treatment of moderate-to-severe eczema of long duration in two multicenter, double-blind, vehicle-controlled, randomized studies. One of the two study medications (up to 100 gm/week) was applied topically to the affected areas of the body twice daily for up to four consecutive weeks. Drug efficacy was measured in terms of three variables: the physician's gross assessment of clinical response of the target lesion, severity scores of individual signs and symptoms, and the patient's subjective assessment of treatment effects. Efficacy and safety were evaluated after seven, fourteen, twenty-one, and twenty-eight days of treatment. The total number of patients in the two studies was 372 (203 in study 1 and 169 in study 2). Fluticasone propionate ointment, 0.005%, was more effective than vehicle at all postbaseline visits in both studies (study 1 P < or = 0.015, study 2 P < or = 0.018). In study 1, approximately 80% of the patients on fluticasone were rated as cleared, excellent, or good by the investigators at treatment endpoint, compared with 38% of those receiving vehicle. In study 2, the sum of 80% of the fluticasone-treated patients was rated as cleared, excellent, or good by the investigators at the end of the study, compared with 34% of those receiving vehicle. The beneficial effect of fluticasone ointment, 0.005%, was early and sustained and was particularly noticeable for pruritus, erythema, and skin thickening. In study 1, no drug-related adverse events were reported in the fluticasone group. Four patients (4.3%) in the vehicle group experienced a total of four drug-related adverse events. The most common was burning/stinging, reported by two patients. In study 2, two patients (2.4%) in the fluticasone-treated group and three (4.1%) in the vehicle group reported a total of five drug-related adverse events, the most common event being pruritus (fluticasone group one patient, vehicle group two patients). These findings show that fluticasone propionate ointment, 0.005%, applied twice daily, is therapeutically superior to the vehicle and is well tolerated.
Vitiligo vulgaris is an autoimmune pigmentary disorder with no universally efficacious therapeutic options. Separate applications of calcipotriene ointment 0.005% and topical corticosteroid ointments have been successful in the repigmentation of vitiligo. We sought to examine the efficacy of a combination calcipotriene 0.005%-betamethasone dipropionate 0.064% ointment in the repigmentation of vitiligo. An institutional review board-approved retrospective chart review was conducted in 13 pediatric and adult patients with vitiligo treated with calcipotriene 0.005%-betamethasone dipropionate 0.064% ointment once daily for at least 2 months. Two of 3 children had 76% to 100% repigmentation of facial vitiligo with once-daily usage after 2 months. Of the 10 adults (aged 28-55 years), 1 had 100% facial repigmentation in 3 months, 1 had 76% to 99% facial repigmentation in 5 to 9 months, and 2 had 26% to 50% repigmentation in 3 months. Twelve patients developed some facial repigmentation. No patients experienced atrophy, telangiectases, or lesion enlargement during treatment. Combination calcipotriene 0.005%-betamethasone dipropionate 0.064% ointment shows promise as a once-daily vitiligo therapy. Adult and pediatric facial vitiligo patients may see repigmentation as early as 2 months after initiation of therapy. Children may experience a better response, but larger studies are needed.
The efficacy and safety of twice-daily topical application of fluticasone propionate ointment, 0.005%, and hydrocortisone-17-butyrate ointment, 0.1%, were compared in 113 adult patients with moderate-to-severe psoriasis in a multicenter, double-blind, randomized, parallel study. The majority of patients had psoriatic involvement of long duration over a large body surface area (mean, 17%). The following efficacy assessments were made at weekly intervals for up to four weeks following initiation of treatment: physician's gross assessment of clinical response of the target lesion; severity of psoriatic signs and symptoms; and patients' assessment of treatment effects. Safety was assessed by monitoring and reporting any adverse events that occurred during the study. Fluticasone propionate ointment, 0.005%, was found to be therapeutically superior to hydrocortisone-17-butyrate ointment, 0.1%, as well as safe and well tolerated. Its onset of action was rapid and no systemic adverse effects occurred. Overall patients experienced progressive improvement with fluticasone propionate ointment, 0.005%.
A randomized, double-blind, parallel group study involving thirteen centers compared the safety, tolerability, and efficacy of twice-daily applications of fluticasone propionate ointment, 0.005%, and betamethasone-17, 21-dipropionate ointment, 0.05%, in ninety-two patients with moderate-to-severe eczema. Safety assessments included routine clinical laboratory evaluations, morning plasma cortisol levels, and reporting of adverse events. Efficacy assessments included (1) physician's gross assessment of clinical response of the target lesion, (2) severity of signs and symptoms of eczema, and (3) patients' assessment of treatment effects. Both treatments were well tolerated and showed minimal suppression of the hypothalamic-pituitary-adrenal axis as evidenced by morning plasma cortisol concentration determinations. Statistically significant improvement in the severity of each sign/symptom was found as early as two weeks following treatment initiation in both groups. The two treatments were found to be similar following two and four weeks of therapy with regard to almost all efficacy variables.
The efficacy, safety, and tolerability of the mid-potency corticosteroid, fluticasone propionate ointment, 0.005%, were compared with those of a high-potency corticosteroid, betamethasone-17,21-dipropionate ointment, 0.05%, in a twelve-week randomized, double-blind, parallel-group, multicenter study of seventy-four patients with moderate-to-severe psoriasis. Efficacy was evaluated for four weeks; safety was evaluated over a twelve-week period. Fluticasone ointment, 0.005%, was not significantly different from betamethasone ointment, 0.05%, at day 15 (P = 0.147), at the end of treatment analysis (P = 0.245), or at day 29 (P = 0.154). Neither medication resulted in any abnormal laboratory values over the twelve-week study period, including plasma cortisol levels. Both medications were well tolerated.
Calcipotriene ointment is widely used in the topical treatment of psoriasis, with tacrolimus ointment as an effective alternative in controlling stable plaque psoriasis. The efficacy of the combination of both products on stable plaque psoriasis has not been assessed in the literature consulted. We evaluated the efficacy of calcipotriene ointment 0.005% applied twice daily, tacrolimus ointment 0.1% applied twice daily, or a morning application of calcipotriene and an evening application of tacrolimus in 27 participants with stable plaque psoriasis over an 8-week treatment period. The mean reduction in the sum of the scores between baseline and week 8 was significant (P = .001) for calcipotriene alone (39.5%), tacrolimus alone (38.2%), and the combination of calcipotriene and tacrolimus (60.7%). Combination therapy was statistically more effective than tacrolimus alone (P = .043) but not statistically superior to calcipotriene alone (P=.056). Most adverse events (AEs) were related to skin irritation and pruritus; however, no AEs were evident in participants given the combination therapy.
Two multicenter, double-blind, randomized, vehicle-controlled parallel-group trials involving 388 patients were conducted to compare the efficacy and safety of fluticasone propionate 0.005% ointment to those of its vehicle in the treatment of moderate-to-severe psoriasis. The study medication (up to 100 gm/week) was applied topically to the affected target areas of the body twice daily for up to four consecutive weeks. Efficacy and safety were evaluated after one, two, three, and four weeks of treatment. In both studies, fluticasone ointment was clearly shown to be superior to vehicle throughout the four weeks of treatment. At the end of the treatment period, the superiority of fluticasone ointment was statistically significant for all efficacy measures. At the end of study 1, the skin of ten of eighty-eight patients (11%) who received fluticasone were rated as cleared by the investigators and fifty (57%) were rated as excellent or good. Of those who received vehicle, the skin of one of ninety (1%) was rated cleared and twenty-five (28%) were rated excellent or good. In study 2, the skin of three of 105 (3%) patients who received fluticasone were rated as cleared and sixty-nine (66%) were rated as excellent or good at the end of the study. Of those who were treated with vehicle, no patient's skin was rated cleared and thirty of 100 (30%) were rated excellent or good. Adverse events were few and mild. The most common drug-related adverse events were burning and pruritus at the site of application, which occurred in 6% of both the fluticasone-treated patients and those who received vehicle. These findings support the conclusion that fluticasone, 0.005%, ointment is clinically superior to its vehicle in the treatment of psoriasis.
Vehicle formulation plays a major role in patient adherence to topical psoriasis treatments. The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%-betamethasone dipropionate 0.064% for treatment of plaque psoriasis. In our small cohort of 20 participants with mild to moderate plaque psoriasis, the topical suspension formulation was preferred over the ointment, though the difference was not statistically significant (P=.32). Overall, the topical suspension was rated as moderately appealing, while the ointment was rated as slightly appealing (P=.06). Subgroup analyses were limited due to the small sample size. The results of this study may provide clinicians with an alternative topical treatment of plaque psoriasis that provides the benefits of a combination product. In clinical practice, it may be best to offer patients both formulations and they can choose the product that is right for them.
Melasma is a common hyperpigmentation disorder that typically affects women, though up to 10% of white individuals seeking treatment for melasma are men. Melasma can be a source of embarrassment for men because of its association with women and pregnancy. We performed a case series assessing the use of mequinol 2%/ tretinoin 0.01% topical solution in 5 men with melasma. Four of 5 patients achieved complete clearance of melasma at 12 weeks, and 1 patient showed moderate improvement. Side effects were minimal and consisted of stinging in one patient. All patients maintained results at the 16-week follow-up visit. Mequinol 2%/tretinoin 0.01% topical solution was an effective and well-tolerated treatment of melasma in men. The vehicle resulted in good compliance and minimal adverse effects in patients. This is the first report describing the use of mequinol 2%/tretinoin 0.01% topical solution for the treatment of melasma in men; there are no reports in women.
A new topical solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solagé) was compared with its active components, its vehicle, and hydroquinone (HQ) 3% in the treatment of solar lentigines. In a randomized, parallel-group, double-masked study, 216 subjects applied the treatments twice daily for 16 weeks and were followed up for a further 24 weeks. A significantly higher proportion (P < or = .05) of subjects achieved clinical success with mequinol 2%/tretinoin 0.01% compared with HQ 3% as measured by both the lesional pigmentation on the forearm and the physician global assessment at the end of treatment. The proportion of subjects achieving clinical success on the face in the mequinol 2%/tretinoin 0.01% group was consistently higher than that in the HQ 3% group. Some treatment effects remained at the end of the treatment-free follow-up, with trends apparent on the face in favor of mequinol 2%/tretinoin 0.01% over HQ 3%. In all treatment groups, skin-related adverse events were mild or moderate and transient. In conclusion, the mequinol 2%/tretinoin 0.01% solution is a highly effective and well-tolerated treatment for solar lentigines and related hyperpigmented lesions, being superior to HQ 3% for lesions on the forearm and of similar efficacy for lesions on the face.
This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76%) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile. only 3 patients (1%) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57%) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90% of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.
The objective of this open-label, noncontrolled study was to evaluate the safety of a combination solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solagé) with a sunscreen in the treatment of solar lentigines. The study included a total of 406 subjects for a treatment period up to 24 weeks. Efficacy was evaluated clinically by grading the pigmentation level of the treated areas on the face and forearms. A total of 378 subjects were included in the safety population. Of the 173 subjects with skin-related and treatment-related adverse events, severity was reported as mild in 79 subjects, moderate in 71, and severe in 23. Hypopigmentation was observed in 4 subjects and had definitively resolved in 3 of these subjects at the end of the study or after treatment had been discontinued. Halo hypopigmentation was reported in 16 subjects. No allergic reactions were observed. Efficacy evaluation was based on data for 370 subjects. A total of 325 (88%) subjects had facial target lesions almost clear to clear, and a total of 298 (81%) subjects had forearm target lesions almost clear to clear. Our study shows that the mequinol 2%/tretinoin 0.01% solution is effective, convenient, and safe in the treatment of solar lentigines.
Ingenol mebutate gel is a topical field treatment of actinic keratosis (AK). One of several proposed mechanisms of action for ingenol mebutate is induction of cell death in proliferating keratinocytes, suggesting a preferential action on AKs rather than healthy skin. Local skin reactions (LSRs) during 2 sequential 4-week cycles of AK treatment with ingenol mebutate gel 0.015% on the face or scalp were evaluated to test the hypothesis that reapplication of the study product would produce lower LSR scores than during the first treatment cycle. In this unblinded study, 20 participants with AKs on the face or scalp were treated with ingenol mebutate gel 0.015% once daily for 3 days in 2 sequential 4-week cycles. Composite LSR scores were evaluated during both cycles. The composite LSR score during the second cycle was found to be significantly lower than the first cycle (P=.0002). The proportion of participants who experienced LSRs in the second treatment cycle was less than the first cycle. Ingenol mebutate gel 0.015% may cumulatively reduce the burden of sun-damaged skin over 2 treatment cycles by targeting and removing transformed keratinocytes.
In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been shown to be safe and effective in the treatment of fine facial wrinkles, mottled hyperpigmentation, and skin roughness. To provide additional prescribing flexibility for various patient needs, a new lower concentration formulation, tretinoin cream 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical., studies were conducted to evaluate the safety and efficacy of the lower concentration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile. Both studies demonstrated that tretinoin cream 0.02% is safe and effective for the treatment of moderate-to-severe photodamaged facial skin.
Topical tretinoin is highly effective and widely used in the treatment of acne vulgaris. Tretinoin gel microsphere 0.1% (TGM)--alone or in combination with erythromycin-benzoyl peroxide (EBP) or clindamycin-benzoyl peroxide (CBP) topical gels-and tretinoin gel 0.025% (TG)--alone or, combined with EBP-were exposed to simulated solar UV irradiation to determine the degree of tretinoin photodegradation/isomerization. The investigation revealed that 94% and 84% of the initial tretinoin in the TGM formulation remained stable after 2 and 6 hours, respectively, of simulated solar UV irradiation. When combined with EBP topical gel, 89% and 81% of the initial tretinoin remained stable after 2 and 6 hours, respectively, of exposure to simulated solar UV irradiation; 86% and 80% of the tretinoin remained stable after 2 and 6 hours, respectively, when combined with CBP topical gel. In contrast, only 19% and 10% of the tretinoin remained unchanged after 2 and 6 hours, respectively, of simulated solar UV irradiation of TG. Combined with the EBP topical gel, undegraded tretinoin quantities were further reduced to 7% and 0% at 2 and 6 hours, respectively, with TG. These data suggest that the TGM formulation offers marked protection against tretinoin photodegradation compared with TG, even in the presence of a topical gel containing a potent antibiotic or a strong oxidizing agent. Although simulated solar UV irradiation is not entirely reflective of actual conditions, the results appear to be substantial.
Tretinoin gel microsphere, 0.1%, is a highly effective anti-acne medication formulated with sponge-like microspheres encapsulating the active ingredient, tretinoin. In addition to minimizing cutaneous irritation, this system may also reduce facial shine. This single-center, double-blind, half-face study evaluated the potential of tretinoin gel microsphere, 0.1%, to reduce the appearance of facial shine compared to tretinoin cream, 0.025%. Thirty-five subjects (ages 12 to 24 years) with moderate acne vulgaris and moderate facial oiliness, were evaluated after 4 consecutive days of product use. On sides treated with tretinoin gel microsphere, 0.1%, investigators found significantly reduced facial shine at 3 and 6 hours posttreatment. Subjects' self-evaluations revealed a significant reduction in facial shine at 3 hours posttreatment. Photographic analyses showed reductions in facial shine for both treatments, but decreases were greater on tretinoin gel microsphere, 0.1%-treated sides. Both therapies were well tolerated, and no adverse events occurred. Tretinoin gel microsphere, 0.1%, has the added benefit of reducing the appearance of facial shine, which is a frequent concern in acne patients.
The multiple etiologic factors involved in acne vulgaris make the use of several medications necessary to treat the condition. Use of a fixed combination of clindamycin phosphate 1.2% and tretinoin 0.025% in conjunction with a benzoyl peroxide (BPO) wash 4% targets several pathologic factors simultaneously and mitigates the potential for clindamycin-induced Propionibacterium acnes-resistant strains. New formulations may allow such regimens to be effectively used without overly reduced tolerability resulting from the irritation potential of tretinoin and BPO. This randomized, single-blind study investigated the local tolerability, irritation potential, and safety of an aqueous-based gel (clindamycin phosphate 7.2%-tretinoin 0.025% [CT gel]) when used in conjunction with a BPO wash 4% in participants with mild to moderate acne vulgaris. Participants applied the CT gel once daily in the evening for 4 weeks in conjunction with once-daily morning use of either BPO wash 4% or nonmedicated soap-free cleanser lotion (SFC). Local tolerability and irritation potential were assessed by participants and investigators using separate 6-point scales. The frequency and severity of dryness, scaling, erythema, burning/stinging, and itching increased during the first week of treatment in both treatment arms but decreased thereafter. Local tolerability reactions were slightly more frequent in the CT gel + BPO wash group versus the CT gel + SFC group at week 1 but were generally mild and improved within 1 to 2 weeks. In conclusion, therapy with CT gel + BPO wash appears safe and well-tolerated in participants with mild to moderate acne vulgaris.
Tazarotene 0.1% gel and tretinoin 0.025% gel are both effective in the treatment of acne vulgaris. Results of a multicenter, double-blind, randomized, parallel-group study that compared the efficacy and tolerability of these drugs are presented here. A total of 143 patients with mild-to-moderate facial acne vulgaris were randomized to receive tazarotene 0.1% gel or tretinoin 0.025% gel once daily for 12 weeks. Tazarotene 0.1% gel was more effective than tretinoin 0.025% gel in reducing the open comedo count (P < or = .05), the total noninflammatory lesion count (P < or = .05), and the total inflammatory lesion count (not statistically significant). At some time points, tazarotene was associated with increased irritation, but peeling, erythema, dryness, burning, and itching never exceeded trace levels. We conclude that tazarotene 0.1% gel is more effective than tretinoin 0.025% gel in reducing noninflammatory lesions and similarly effective in reducing inflammatory lesions.
We sought to evaluate the efficacy and tolerability of treating melasma using a 4% hydroquinone skin care system, including a proprietary cleanser, toner, 4% hydroquinone, exfoliation enhancer, and sunscreen, plus tretinoin cream 0.025%. Together these products offer not only treatment of melasma but also a complete skin care regimen. Twenty participants with mild or moderate epidermal melasma with Fitzpatrick skin types III to VI were instructed to use the hydroquinone skin care system and tretinoin cream for 12 weeks. Melasma severity, melasma pigmentation intensity, and melasma area and severity index (MASI) score were significantly reduced from week 4 onward relative to baseline (P < or = .01). The proportion of participants who felt embarrassed or self-conscious about their skin very much or a lot declined from 80% (16/20) to 20% (4/20) between baseline and week 12. Similarly, the proportion of those who made very much or a lot of effort to hide their skin discoloration declined from 90% (18/20) to 37% (7/19). In total, 85% (17/20) of participants were satisfied with the overall effectiveness of the study treatment. Three participants had adverse events probably related to treatment (dryness, erythema, peeling, and stinging sensation). The 4% hydroquinone skin care system plus tretinoin cream 0.025% is effective and well-tolerated in the treatment of melasma.
An aqueous gel formulation containing solubilized clindamycin phosphate 1.2% and a stable combination of both solubilized and crystalline tretinoin 0.025% (clin/tret) has been evaluated in 3 pivotal phase 3 studies, among other studies including a 52-week trial. The pivotal studies enrolled 4550 participants 12 years and older with mild, moderate, and severe acne vulgaris. The combination clin/tret gel was effective in reducing both inflammatory and noninflammatory lesions and was well-tolerated. This article reviews important vehicle characteristics of the combination gel as well as formulation stability and tolerability data that are potentially clinically relevant.
Acne affects as many as 50 million individuals in the United States. Topical therapy combining a retinoid and an antibiotic is recommended as a first-line therapeutic option for mild to moderately severe acne. Although treatment for extended durations may be required, little long-term safety data on these combination therapies are available. This report summarizes the long-term safety and tolerability of a novel combination product for the treatment of acne vulgaris in participants 12 years and older. The combination treatment is a gel formulation containing a crystalline suspension of clindamycin phosphate 1.2%-tretinoin 0.025% (CLIN/RA). Two cohorts participated in a long-term (up to 52 weeks), multicenter, open-label, safety evaluation of CLIN/RA. Treatment duration was 6 months for the first cohort (N = 442) and 12 months for the second cohort (N = 213). Overall, the CLIN/RA gel was well-tolerated; 92%, 91%, and 94% of participants reported no itching, burning, or stinging, respectively. The most frequent adverse events were acne (29/442; 7% [usually a flare]), sunburn (12/442; 3%), hypersensitivity (7/442; 2%), contact dermatitis (5/442; 1%), and application-site desquamation (3/442; 1%). These results confirm the safety of CLIN/RA gel for mild to moderately severe acne. The CLIN/RA gel fixed-dose combination provided minimal adverse events and a favorable safety profile for 2 agents with established efficacy for the treatment of acne vulgaris.
Mometasone furoate (Elocon) is a newly formulated and unique medium-potency synthetic 17-heterocyclic corticosteroid. The efficacy and safety of the ointment and cream formulations (0.1 percent) of the corticosteroid, administered once daily, were compared with those of the ointment and cream formulations of fluocinolone acetonide 0.025 percent administered three times daily and triamcinolone acetonide 0.1 percent administered twice daily in four multicenter clinical studies. They were conducted involving psoriasis patients with chronic and moderate to severe disease. Evaluation of change in disease sign scores indicated that mometasone ointment, applied once daily, was significantly more effective (P less than 0.01) than fluocinolone ointment, applied three times daily, and triamcinolone ointment, applied twice daily. The cream formulation of mometasone was significantly more effective (p less than 0.001) than fluocinolone cream, applied three times daily, and equivalent to triamcinolone cream, applied twice daily. The incidence of local adverse experiences following treatment with the ointment or cream formulations of mometasone was minimal. Mometasone ointment and cream provide a highly effective once-a-day treatment for moderate to severe psoriasis with minimal risk of side effects.
This double-blinded, randomized, vehicle-controlled, multicenter, parallel-group, 12-week, phase 4 study was conducted in adults with mild to moderate acne vulgaris. Of 178 subjects randomized to be treated, 88 subjects (49%) were treated with tretinoin gel microsphere 0.04% and 90 subjects (51%) were treated with vehicle. Inflammatory lesion counts were statistically significantly reduced at 2 weeks in tretinoin-treated subjects (P = .0110), and reductions in total lesion counts also were noted. The reduction in total lesion counts reached statistical significance at week 4 (P = .0305); at week 12, mean total, inflammatory, and noninflammatory lesion counts were statistically significantly lower in the tretinoin treatment group versus vehicle group (P < .05), and mean percentage reductions in lesion counts were significantly greater in the subjects with noninflammatory lesions treated with tretinoin compared with vehicle (P < .05). Mean percentage reductions in total, inflammatory, and noninflammatory lesion counts were 35.5%, 38.2%, and 33.6%, respectively, at week 12 for the tretinoin treatment group compared with 20.9%, 19.2%, and 20.4%, respectively, for the vehicle group (all P < .05). All adverse events were of mild or moderate intensity with the exception of severe skin irritation in one tretinoin-treated subject. At week 12, there were no statistically significant differences between treatment groups for any measured tolerability parameter.
Despite the many beneficial effects of dermatologic applications, most of the current treatments for acne cause local irritation. The objective of this study was to compare the ability of the epidermis to tolerate adapalene 0.1% cream and gel and tretinoin microsphere in concentrations of 0.04% and 0.1%. A total of 31 subjects were enrolled in the study. The test products were applied under occlusive dressings on the upper back for approximately 24 hours, 4 times a week, and for 72 hours, once a week, for a period of 3 weeks. Skin reactions (erythema score plus other local reactions) at the product application sites were assessed 5 to 30 minutes after dressing removal. Twenty-six subjects completed the study. A total of 10 subjects discontinued use of 1 or more of the test products because of irritation scores reaching severe or greater, all of these discontinuations were at sites treated with the tretinoin products. The mean 21-day cumulative irritancy indices for adapalene 0. 1% cream and gel were significantly lower (P<.01) than those for tretirnoin microsphere 0.04% and 0. 1% and not higher than that of the negative control product.
Acne is characterized by different types of lesions at different stages of development. Therefore, combination therapy may offer numerous advantages, including enhanced efficacy and better tolerability. The addition of benzoyl peroxide (BPO) to all long-term antibiotic treatment is widely advocated to help suppress the emergence of antibiotic-resistant bacteria. Topical retinoids are recommended as early initiation treatment of most patients with acne because they target most mechanisms of acne pathogenesis. In the clinical setting, therapeutic regimens that include retinoids and topical antibiotic-BPO combination formulations frequently are prescribed. This study investigated the efficacy and safety of combination therapy with clindamycin 1%-BPO 5% topical gel plus tretinoin microsphere (RAM) gel 0.04% or 0.1% or adapalene (AP) gel 0.1% in moderate to severe acne.
Two clinical trials were conducted to evaluate the safety and antipsoriatic efficacy of a new 0.05 percent emollient formulation of clobetasol propionate (CP). In a crossover study of hypothalamic-pituitary-adrenal (HPA)-axis effects in 12 patients with psoriasis or eczema, 1.5 gm of CP emollient, applied to lesions twice daily for seven consecutive days, resulted in fewer patients with serum cortisol concentrations < 10 micrograms/100 mL than CP cream 0.05 percent (1vs 4); such concentrations were seen in two other patients during both treatment phases. A double-blind, randomized, parallel-group clinical trial in patients with moderate to severe plaque-type psoriasis showed that four weeks' treatment with CP emollient 0.43 to 0.5 gm twice daily (n = 35) was significantly more effective than emollient vehicle (n = 39) in reducing total signs/symptoms and scaling by Day 4, erythema and skin thickening by Day 8, and pruritus by Day 15. CP emollient was rated superior to vehicle by Day 4 in physician's gross assessment ratings and by Day 15 in patient's self-assessment ratings. In all assessments, CP emollient continued to be superior to vehicle during the remainder of the treatment period and two-week posttreatment period. No significant differences were observed in tolerability or serum cortisol effects during the course of the study.
Fifty psoriatic patients enrolled in a three week, double-blind, randomized, parallel study were treated either with amcinonide ointment 0.1 percent twice a day or fluocinonide ointment 0.05 percent three times a day. After Week 1 of treatment, no statistically significant differences appeared between the two groups with regard to improvement in signs and symptoms of psoriasis. After Week 3, improvement in all efficacy parameters, except erythema, and in Total Scores in both groups was greater than 50 percent as compared to baseline evaluations. There were no statistically significant differences between the treatment groups. Only one patient in each group reported an adverse experience that could have been drug-related. Amcinonide ointment used twice a day and fluocinonide ointment used three times a day were judged comparable with regard to safety and clinical efficacy. Amcinonide may be considered to have some advantage over fluocinonide because its twice a day treatment schedule makes it more convenient for patients to use.
To compare the atrophogenic effects of fluocinonide cream 0.1% versus clobetasol propionate cream 0.05%, 20 participants with corticosteroid-responsive dermatoses were randomly assigned to receive fluocinonide cream 0.1% on one arm and clobetasol propionate cream 0.05% on the other arm. Study medications were applied to disease-free target areas on the inner arms twice daily for 2 weeks. The epidermal thickness of pretreatment and posttreatment punch biopsy specimens was measured. Skin examinations were performed evaluating clinical signs of atrophy. No significant reduction in epidermal thickness was observed in the fluocinonide-treated sites (mean, -0.0318 mm; standard deviation, 0.0239; P=.1991). A significant reduction in epidermal thickness was seen in the clobetasol-treated sites (mean, -0.1825 mm; standard deviation, 0.0239; P<.0001). This reduction was significantly greater than results from sites treated with fluocinonide cream 0.1% (difference, -0.1507; standard deviation, 0.0131; P<.0001). Although topical corticosteroids often are the first-line treatment for patients with various dermatoses, a side effect of continuous use is cutaneous atrophy. Our study demonstrated that clobetasol propionate cream 0.05% caused a significantly greater reduction in epidermal thickness compared with fluocinonide cream 0.1% when used twice daily for 2 weeks (P<.001). However, neither drug caused significant clinical signs of atrophy.
Controlled clinical trials provide important information about medications. However, although controlled clinical trials typically assess the use of a medication by itself or in a single combination, combinations and adjunctive use of multiple medications frequently are used in the care of patients with psoriasis. The Clobex Spray Community-Based Research Assessment (COBRA) trial, a large, 4-week, open-label, observational, community-based trial, assessed the use of twice-daily clobetasol propionate spray 0.05% as an add-on therapy to an existing therapeutic regimen in subjects (n = 731) with moderate to severe plaque psoriasis affecting 3% to 20% body surface area (BSA). The key outcome measures were the change in target plaque severity (TPS) and investigators' global assessment of improvement (GAI) at week 4. Tolerability, quality of life (QOL), and subject satisfaction also were assessed. After 4 weeks of treatment, 80.0% of subjects in the add-on therapy group were clear or almost clear, according to the TPS scale, or had an improvement in severity from baseline by 2 grades (P < .001); 62.0% of subjects were completely cleared or almost completely cleared at week 4 according to the GAI scale (P < .001). Tolerability ratings of severe for erythema, peeling/ scaling, dryness, and stinging/burning occurred in less than 1.0% of subjects at week 4, and a rating of moderate occurred in only 1.6% to 4.1% of subjects. In addition, 94.0% of subjects in the add-on therapy group were reported as being very satisfied or somewhat satisfied with their therapy at week 4. Clobetasol propionate spray 0.05% was highly effective and well-tolerated as part of a wide range of therapeutic strategies.
Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not always induce complete clearing in patients. In many instances, physicians supplement biologic treatment with topical agents as adjunctive therapy to obtain additional clearing of plaques. To evaluate the effectiveness of the addition of a superpotent corticosteroid--clobetasol propionate spray 0.05%--to various psoriasis treatments, a phase 4, multicenter, open-label, community-based trial was conducted. In this study, clobetasol propionate spray 0.05% applied twice daily was added on to a variety of existing stable treatments including systemic biologic agents in participants with moderate, severe, or very severe plaque psoriasis. The decision to add clobetasol propionate spray 0.05% to stable psoriasis therapy was determined by each investigator based on his/her evaluation of a participant's needs. A total of 159 participants from the trial adhered to stable (> or = 3 months' duration) therapeutic regimens that included a biologic treatment. In this population, at the end of the study period, 81.0% of participants with moderate disease at baseline, 79.5% of participants with severe disease at baseline, and 58.8% of participants with very severe disease at baseline were rated as clear or almost clear (target plaque severity [TPS]). Worst skin tolerability response was assessed postbaseline and included erythema (20.3% mild, 8.9% moderate, 1.9% severe), peeling (26.6% mild, 7.0% moderate, 1.3% severe), dryness (34.8% mild, 8.9% moderate, 1.3% severe), and stinging (25.3% mild, 3.8% moderate, 0.6% severe). Telangiectasia and skin atrophy were reported in 1.3% of participants each at some point during the study (postbaseline). Pruritus was reported in 7.6% of participants and folliculitis was reported in 1.9% of participants. Eight participants experienced adverse events (AEs) that were regarded as probably related to the study medication (clobetasol propionate spray 0.05%). Because those participants who entered the study already were receiving one medication (the biologic agent), it is believed that most of the reported AEs were due to the addition of clobetasol propionate spray 0.05%, and those AEs associated with the biologic agent and/or the combination of the two may be underreported. Although the results of this study are intriguing, further research is needed to evaluate if the addition of topical therapies, such as superpotent corticosteroids, are effective and safe options for treating psoriasis plaques when control with biologic therapy is not fully effective on its own.
Seborrheic dermatitis (SD), a common dermatosis associating hyperseborrhea, erythema, itching, and dandruff, has frequent scalp involvement. Malassezia furfur infection seems to play an important role in the condition's etiopathology. Treatment of SD usually consists of corticosteroids or antifungals, such as ketoconazole. The aim of this multicenter, randomized, investigator-blinded, parallel-group pilot study was to evaluate the efficacy and safety of clobetasol propionate shampoo 0.05% after different short-contact application times compared with its vehicle and ketoconazole foaming gel 2% in the treatment of SD of the scalp. For 4 weeks, 55 subjects received one of the following treatments twice weekly: clobetasol propionate shampoo for 2.5, 5, or 10 minutes; clobetasol propionate vehicle for 10 minutes; or ketoconazole foaming gel for 5 minutes before rinsing off. Efficacy criteria included total severity score (TSS) and individual scores of signs such as itching and global improvement. Safety included reporting of burning, overall tolerance, and adverse events. Results showed that an application of clobetasol propionate for 5 and 10 minutes provided a similar mean percentage decrease of TSS, and the mean percentage decrease of TSS for all active groups was significantly superior to that of the vehicle (P < .01). Overall and local safety were good for all treatment groups. The present pilot study demonstrated that a short-contact application of clobetasol propionate shampoo is effective and safe in the treatment of SD of the scalp.
Investigators conducted two double-blind, randomized, parallel-group trials to compare the efficacy of fluticasone propionate cream, 0.05%, and betamethasone valerate cream, 0.1%, in the treatment of moderate-to-severe psoriasis. Up to 100 gm/week of the study medication was applied topically to affected areas of the body twice daily for up to four consecutive weeks. Efficacy and safety were evaluated after seven, fourteen, twenty-one, and twenty-eight days of treatment. The data from the participating sites show that fluticasone propionate cream, 0.05%, was as efficacious as betamethasone valerate cream. Investigators found no statistically significant differences between the two products by any of the three variables used to gauge efficacy (P > 0.05). Drug-related adverse events were few and mild. These findings support the conclusion that fluticasone propionate cream, 0.05%, is effective and well tolerated when used to treat moderate-to-severe psoriasis and is comparable to a widely used midpotency topical steroid.
The Clobex Spray Community-Based Research Assessment (COBRA) trial, a large, 4-week, open-label, observational trial, evaluated the use of twice-daily clobetasol propionate spray 0.05% in subjects with moderate to severe plaque psoriasis affecting 3% to 20% body surface area (BSA). The study was designed to augment existing phase 3 clinical trial data. In this trial, 1254 subjects in the effectiveness-evaluable (EE) population were treated with clobetasol propionate spray 0.05% as monotherapy. Clinical effectiveness was evaluated at weeks 2 and 4 using a 6-point target plaque severity (TPS) scale and 7-point investigators' global assessment of improvement (GAI) scale. Psoriasis TPS at week 0 (baseline) was rated as moderate to severe in more than 90% of subjects. After 2 weeks of clobetasol propionate spray 0.05% monotherapy, statistically significant improvement in TPS was seen at weeks 2 and 4 (P < .001). In addition, statistically significant improvement was seen at week 4 versus week 2 (P < .001) using the GAI scale. Clobetasol propionate spray 0.05% monotherapy was well-tolerated as assessed by erythema, peeling/scaling, dryness, stinging/burning, telangiectasia, skin atrophy, pruritus, and folliculitis. Skin and subcutaneous tissue disorders as well as general disorders and application-site conditions defined as possibly or probably related to therapy occurred in 1.0% and less than 1.0% of subjects, respectively. In addition, more than 90% of subjects were reported by investigators as being very satisfied or somewhat satisfied with their treatment at week 4. Based on these data, clobetasol propionate spray 0.05% is an effective and convenient topical monotherapy for moderate to severe plaque psoriasis.
Desonide ointment has demonstrated a good safety and efficacy profile during the many years it has been used in treating dermatoses. However, there have been no controlled clinical trials to evaluate its systemic safety when used in treating children. Suppression of the hypothalamic-pituitary-adrenal (HPA) axis can occur after repeated application of topical corticosteroids. In general, the degree of suppression of the HPA axis function is related to the daily dosage of steroid given, the duration of its administration, the extent of body surface covered, and the potency of the corticosteroid. This study sought to determine the comparative effects of 0.05 percent desonide and 2.5 percent hydrocortisone ointments on the HPA axis of children with atopic dermatitis. There was no suppression of early morning cortisol in either treatment group. The ACTH-stimulated mean cortisol values after four weeks of treatment were not significantly different from the baseline values for either treatment group. We conclude that neither 0.05 percent desonide ointment nor 2.5 percent hydrocortisone ointment compromised the HPA axis of children with atopic dermatitis treated topically for four weeks.
Acne vulgaris is common in young adolescents. Retinoids are widely used but may be associated with poor tolerability. This post hoc analysis of 483 participants aged 10 to 14 years with mild to moderate acne compared efficacy and tolerability of once-daily treatment with micronized tretinoin gel 0.05%, tretinoin gel microsphere 0.1%, and vehicle over 12 weeks. In study 1, inflammatory and noninflammatory lesion reduction and treatment success was comparable between tretinoin gel 0.05% and tretinoin gel microsphere 0.1%. Inflammatory (46.3%) and noninflammatory (45.7%) lesion reductions with tretinoin gel 0.05% were significantly greater than vehicle (37.1% and 27.9%, respectively) (both P<.001). In study 2, inflammatory and noninflammatory lesion reductions and treatment success with tretinoin gel 0.05% (30.6%, 39.1%, and 19%, respectively) were significantly greater than vehicle (10.9%, 16.9% [both P<.001], and 4% [P=.008], respectively). Tretinoin gel 0.05% was significantly better tolerated than tretinoin gel microsphere 0.1% (P<.001); the majority of adverse events (AEs) were mild, occurring in the first 2 weeks. Fourteen percent of participants reported dry skin, 8% skin burning sensation, 5% erythema, and 5% dermatitis exfoliative with tretinoin gel 0.05% compared with 32%, 11%, 23%, and 23%, respectively, with tretinoin gel microsphere 0.1% (all P<.001, except skin burning sensation). In this secondary analysis of acne in young adolescents aged 10 to 14 years, micronized tretinoin gel 0.05% provided a comparable lesion reduction and treatment success versus tretinoin gel microsphere 0.1%, with a better cutaneous tolerability profile.
For topical medications commonly used to treat dermatologic conditions, outcomes may be affected by the choice of delivery vehicles. The aim of this study was to compare quality of life (QOL), effectiveness, user satisfaction, and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days. In a single-blind design, 32 patients randomized into 2 groups applied either clobetasol foam 0.05% to the skin and scalp or combination clobetasol cream 0.05% to the skin and clobetasol solution 0.05% to the scalp. Psoriasis severity was measured using the standardized Psoriasis Area and Severity Index (PASI) and self-administered PASI (SAPASI). QOL was assessed via the EuroQoL-5D (EQ-5D) questionnaire and Dermatology Life Quality Index (DLQI). Cost-effectiveness was measured by the amount of medication used per body surface area (BSA) treated and by cost per point improvement in PASI score. In this study, a foam formulation performed better than a cream/solution combination by several measures. A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution (mean decrease in PASI=5.0 vs 3.3, P=.05). The PASI score in the foam group decreased by 41% versus 35% in the cream/solution group (P=.17). In scalp psoriasis, the group using the foam had greater improvement in both absolute (P=.03) and percentage (P=.03) terms and than the solution group. When measuring global QOL, foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute (P=.05, P=.02) and percentage (P=.04, P=.02) terms (first and second survey components, respectively). Differences in improvement of skin-specific QOL, quantified by DLQI scores between groups, were suggested but not statistically significant. Patients using foam spent less time applying medication compared with previous topical medications (P<.001). No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA (8.18 dollars vs 7.05 dollars per percentage BSA affected, P=.30).
A multicenter open clinical evaluation of 0.05 percent betamethasone dipropionate in optimized cream vehicle for the treatment of psoriatic lesions was conducted to investigate its efficacy. There were 348 patients with moderate to severe psoriasis who completed the three-week clinical trial. Three hundred and ten patients used the cream twice a day and another 38 patients used it once a day. All patients responded well to treatment. Significant improvement was observed at all follow-up visits on days 8, 15, and 21 (p less than 0.001) for measures of erythema, induration, and scaling of lesions. The response was equally impressive whether the patient's psoriatic status prior to the treatment was stable or worsening, involved more than 50 percent of the skin surface or less, or had lasted more than ten years or less. The response of psoriasis to once-a-day application of cream was as good as that seen with twice-a-day application. Side effects, noted in a small percentage of patients, were burning, dry skin, and pruritus. We conclude that the cream is a safe and highly effective treatment for psoriasis. The once-a-day application is probably adequate for control of psoriasis.
Clobetasol propionate (CP) shampoo 0.05% is an efficacious and safe treatment for scalp psoriasis. The aim of this double-blind, randomized, placebo-controlled study was to determine if CP shampoo is suitable for long-term disease control. Participants with moderate to severe scalp psoriasis (global severity score [GSS] of 3 or 4 on a scale of 0 [clear] to 5 [very severe]) first received once daily CP shampoo treatment for up to 4 weeks. Responders were subsequently randomized to receive the CP shampoo or vehicle twice weekly maintenance regimen for up to 6 months. When relapse occurred (defined as GSS > 2), participants resumed once daily CP shampoo treatment; when symptoms diminished (GSS < or = 2), they readopted the twice weekly maintenance regimen. At all visits significantly more participants treated with CP shampoo did not relapse compared with participants treated with vehicle (P < .001). Only approximately one-third of participants treated with vehicle remained relapse free at 1 month, while this rate was observed approximately 3.5 months later (4.5 months after baseline of maintenance phase) in the CP shampoo group. After 6 months 31.1% (33/106) of participants in the CP shampoo group were still relapse free versus 8.1% (9/111) of participants in the vehicle group. There was no greater incidence of skin atrophy, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression in the CP shampoo group compared with the vehicle group. Clobetasol propionate shampoo is efficacious and safe for acute management and long-term maintenance of moderate to severe scalp psoriasis.
This multicenter, double-blind, randomized, parallel, four-week, vehicle-controlled study compared the efficacy and safety of once- and twice-daily application of fluticasone propionate cream, 0.05%, over a twenty-eight-day treatment period in 238 patients with moderate-to-severe eczema. Clinical evaluations, which included the physician's gross assessment, the severity of signs and symptoms, and the patient's subjective evaluation, were conducted at baseline and at weekly intervals following initiation of treatment. Both fluticasone QD and BID were found to be superior to vehicle at each evaluation. Application of fluticasone BID was found to be superior to once-daily application at day 22 based on the physician's gross assessment, and at days 15 and 22 based on the patient's subjective assessment. There were, however, no statistically significant differences between QD and BID application at day 8 and at the end of the twenty-eight-day treatment period. The results of this study suggest that QD application may be recommended for the treatment of moderate-to-severe eczema in most patients. As always, treatment effectiveness should be monitored periodically and BID application may be necessary to maximize therapeutic benefits in some patients.
Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek alternative treatments of patients with plaque psoriasis that provide both efficacy and safety while minimizing exposure to high-potency steroids that can have adverse effects following long-term use. We report an open-label, multicenter study designed to evaluate a morning/evening (AM/PM) treatment regimen involving clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g for moderate plaque psoriasis. Participants applied clobetasol propionate spray 0.05% in the morning and calcitriol ointment 3 microg/g in the evening for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study indicate that a 4-week regimen of clobetasol propionate spray 0.05% treatment in the morning and calcitriol ointment 3 microg/g in the evening is efficacious and without unexpected safety issues for the management of moderate plaque psoriasis.
Thirty-nine patients with psoriasis were treated either with amcinonide ointment 0.1 percent twice a day or with fluocinonide ointment 0.05 percent three times a day in a two-week, randomized, parallel-group, double-blind study. The severities of the skin lesions at baseline and at weekly intervals and the overall improvement at weekly intervals were evaluated by the investigator and the patient. The skin lesions improved significantly (p less than or equal to 0.01) over their condition at baseline, with good overall improvement attained by both treatment groups within one week. Both treatments were well tolerated. Amcinonide ointment 0.1 percent applied twice a day was found to be as effective and acceptable to patients as was fluocinonide ointment 0.05 percent applied three times a day in the treatment of psoriasis.
The efficacy of Diprolene ointment 0.05 percent (betamethasone dipropionate in a glycol formulation) and Dermovate ointment 0.05 percent (clobetasone propionate) and their effects on adrenal function were evaluated in two double-blind, parallel group studies. A fixed dose of 7 gm of ointment a day was applied topically for fourteen days (Study 1) or twenty-one days (Study 2) to the skin of patients with psoriasis or other resistant dermatoses. To evaluate the adrenal effect of the treatments, plasma cortisol levels were determined for twenty of the sixty-one patients in Study 1 and for all of the twenty patients in Study 2. Efficacy and adverse experience data were evaluated for all patients. At the initial visit and at weekly follow-up visits, the selected lesions were graded for the severity of the signs and symptoms of disease. Most of the patients in these studies experienced a complete clearing of all the signs and symptoms of their disease by the end of the treatment with either Diprolene or Dermovate. The two treatments were equally effective. No adverse experiences were seen in the Diprolene group, but one patient with psoriasis in the Dermovate group had an exacerbation of the disease and the treatment was discontinued. In Study 1, reduction in plasma cortisol levels during treatment was observed in both groups, but to a distinctly lesser degree in the Diprolene than in the Dermovate group; levels below the normal range (184 to 767 nmol/l) were observed in one patient in the Diprolene group and in four patients in the Dermovate group.(ABSTRACT TRUNCATED AT 250 WORDS)
Clobetasol propionate is a super-high potent class 1 topical corticosteroid available in several formulations, including a spray formulation that is approved for use up to 4 weeks in patients aged 18 years and older with moderate to severe plaque psoriasis. The efficacy and safety of clobetasol propionate spray 0.05% has been extensively evaluated in clinical trials in more than 2200 patients with moderate to severe plaque psoriasis. This article reviews the efficacy, safety, and tolerability of clobetasol propionate spray 0.05%. Clobetasol propionate spray 0.05% is a topical product with a documented efficacy and safety profile with good acceptability in patients with moderate to severe plaque psoriasis.
A multicenter, double-blind study compared the effectiveness of two highly potent topical corticosteroids in patients with moderate to severe signs of psoriasis. Left/right paired comparisons of clobetasol propionate ointment 0.05 percent, and an optimized formulation of betamethasone dipropionate ointment 0.05 percent, were made in 130 patients with roughly symmetrical psoriatic lesions. The ointments were applied by the patients twice daily, without occlusion, for two weeks. Both drugs were shown to be highly effective and were well tolerated. Significantly more patients showed greater improvement on the side treated with clobetasol propionate. Follow-up evaluation two weeks after the treatment period showed statistically significant (p less than 0.001) longer remissions resulting from the use of clobetasol propionate.
Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.
Scalp psoriasis has a considerable impact on the quality of life (QOL) of patients, and most patients are dissatisfied with available treatments. Clobetasol propionate shampoo 0.05% has been shown to be effective and safe for moderate to severe scalp psoriasis. We evaluated the effect of clobetasol propionate shampoo on QOL and the degree of participant satisfaction with the product. Participants received once-daily treatment for up to 4 weeks. Their QOL and degree of satisfaction were evaluated by questionnaires. The mean (standard deviation) Dermatology Life Quality Index (DLQI) score decreased significantly from 7.0 (4.9) at baseline to 3.2 (3.2) at week 4 (P<.001). Participants who considered the disease as having a small effect or no effect on their QOL increased from 45.6% at baseline to 81.7% at week 4. Most participants were satisfied with the cosmetic acceptability and the efficacy and safety aspects of the product, considered it better than prior treatments, and would use it again in the future. Therefore, we conclude that treatment with clobetasol propionate shampoo improved the QOL of participants and resulted in high satisfaction.